Market Newsdesk

September 16, 2021 3:03 am

KVH Provides AgilePlans VSAT Services for Briese Schiffahrt Vessels and Crew

The AgilePlans program accelerates HTS VSAT adoption as a monthly subscription with no costly CAPEX

MIDDLETOWN, R.I., Sept. 16, 2021 (GLOBE NEWSWIRE) — KVH Industries, Inc., (Nasdaq: KVHI), announces its successful and expanding AgilePlans relationship with established customer German shipmanager Briese Schiffahrt, which has rapidly grown its installed base over the last two years from 5 to 38 vessels with plans to continue. The flexibility of KVH’s no-commitment AgilePlans^® program and the reliability of the global VSAT services in supporting critical operational usage and crew communications were cited by the company as reasons for selecting KVH.

“For us, it is very important to work with a company that is able to provide the ease and flexibility of paying monthly without any commitment worries,” says Holger Börchers, IT manager for Briese Schiffahrt. “It shows that KVH understands the commercial maritime market and the fact that fleet sizes change.” He adds: “KVH AgilePlans provides full coverage of all fees in one price and we have found working with KVH to be seamless.”

The arrangement was facilitated by Heiko Höfer, managing director of Dualog Nordic GmbH, KVH’s airtime service provider in Germany. “Our success here is owing to the close-knit relationships of trust, support, and dependability that have been forged in the local market over many years,” says Thomas Plüschau, KVH regional sales manager for Germany. “These strong and positive working relationships, combined with the power of AgilePlans, enables us to help drive change, modernization, and business in critical shipping hubs.”

Briese Schiffahrt manages a fleet of project cargo vessels, bulk carriers, and containerships, and also performs crew management for more than 2,000 seafarers. The shipmanager values KVH’s satellite connectivity services for the improved communications between office and vessels and for the ease of managing crew accounts, according to Mr. Börchers. “Every morning, our crew program is synchronized and when a seafarer steps on a KVH-equipped vessel, it automatically recognizes the crew member and provides the appropriate Internet access,” he says. “We know that we need to offer good connectivity in order to get and keep good crew members. Our plan is to equip every vessel that is sailing on waters more than 50 miles from the coast with VSAT.”

Nearly all of the 38 KVH-equipped Briese Schiffahrt vessels use the TracPhone^® V7-HTS, a 60 cm diameter satellite communications antenna system designed to provide data speeds up to 10 Mbps down/3 Mbps up. Two vessels use the TracPhone V3-HTS, a 39 cm diameter system featuring data speeds up to 6 Mbps down/2 Mbps up, and one vessel uses the TracPhone V11-HTS, a 1-meter diameter system featuring data speeds up to 20 Mbps down/3 Mbps up. Mr. Börchers adds: “Briese will build a number of new vessels during the next years and all of them will be equipped with a KVH V11-HTS. The very first of this new generation is planned to be delivered in mid-November.”

The AgilePlans program also includes the NEWSlink^TM service, which enables seafarers on the Briese Schiffahrt vessels to access daily news content from around the world, an important aspect of crew welfare. The NEWSlink service includes more than 65 national seafarer news dailies in more than 20 languages, plus monthly special interest editions.

KVH AgilePlans is a Connectivity as a Service (CaaS) subscription-based model offering a comprehensive solution for maritime satellite communications. Without a costly capital outlay, the AgilePlans service eliminates barriers to upgrading to VSAT or switching from a competitor. It includes high-speed connectivity with unlimited email and texting via KVH’s mini-VSAT Broadband^SM HTS network, TracPhone HTS-series hardware, installation in as many as 4,000 ports and locations, cybersecurity protection, NEWSlink print and TV news content, KVH OneCare^TM maintenance, and no long-term commitment, all for one monthly fee.

KVH’s HTS network utilizes Intelsat’s FlexMaritime service to deliver global multi-layered coverage, enabling vessels to see multiple HTS and wide beam satellites for maximum availability of broadband service.

Note to Editors: For more information about KVH AgilePlans, please visit kvh.com/agileplans. High-resolution images of KVH products are available at the KVH Press Room Image Library, kvh.com/Press-Room/Image-Library.

About Briese Schiffahrt

Briese Schiffahrt, headquartered in Leer, Germany, manages a fleet of more than 130 multipurpose vessels including project cargo vessels, bulk cargo vessels, and containerships. The company provides a wide range of integrated maritime services and is committed to high safety standards, state-of-the-art equipment, and qualified and well-trained crews.

About KVH Industries, Inc.

KVH Industries, Inc., is a global leader in mobile connectivity and inertial navigation systems, innovating to enable a mobile world. A market leader in maritime VSAT, KVH designs, manufactures, and provides connectivity and content services globally. KVH is also a premier manufacturer of high-performance sensors and integrated inertial systems for defense and commercial applications. Founded in 1982, the company is based in Middletown, RI, with research, development, and manufacturing operations in Middletown, RI, and Tinley Park, IL, and more than a dozen offices around the globe.

This press release contains forward-looking statements that involve risks and uncertainties. For example, forward-looking statements include statements regarding the success of our strategic initiatives; our anticipated revenue and the impact of our future initiatives on revenue; competitive positioning and profitability; expected data speeds over our network and the expected level of coverage availability; and the services to be provided under agreement with Briese Schiffahrt. The actual results we achieve could differ materially from the statements made in this press release. Factors that might cause these differences include, but are not limited to, the uncertain duration of the adverse impact on our overall revenues of our AgilePlans, under which we recognize no revenues for product sales, either at the time of shipment or over the contract term; delays in the receipt of anticipated AgilePlans service orders; the potential failure of such AgilePlans orders to occur at all and the customer’s ability to cancel AgilePlans at any time; increased costs arising from the new HTS network; potential levels of customer demand for data services beyond our current expectations, which could exceed system capabilities in certain regions; and potential unforeseen costs or expenses of providing the products and services included in AgilePlans. These and other factors are discussed in more detail in KVH’s Form 10-Q filed with the SEC on July 30, 2021. Copies are available through its Investor Relations department and website, investors.kvh.com. KVH does not assume any obligation to update its forward-looking statements to reflect new information and developments.

KVH Industries, Inc., has used, registered, or applied to register its trademarks in the U.S.A. and other countries around the world, including but not limited to the following marks: KVH, AgilePlans, NEWSlink, mini-VSAT Broadband, TracPhone, and KVH OneCare. All other trademarks are the property of their respective companies.

For further information, please contact:

Jill Connors
Sr. Manager, Media & Industry Analyst Relations
KVH Industries, Inc.
Tel: +1 401 851 3824
[email protected]

September 16, 2021 2:48 am

MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021

21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A
78% of patients had tumor shrinkage at first scan
Median duration of response was 10.3 months as of data cutoff
Margetuximab plus retifanlimab was well tolerated with Grade 3 treatment-related adverse events (TRAEs) in 19% of patients; no Grade 4 TRAEs or treatment-related deaths
Findings suggest this chemotherapy-free combination, if validated and approved, may be a potential option for first-line HER2+ patients

ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab. MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ gastric cancer (GC) or gastroesophageal junction (GEJ) cancer in combination with a checkpoint inhibitor, with or without chemotherapy. The dataset is available in a poster titled “Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A” (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

The efficacy data and safety cutoff dates were July 19, 2021 and August 3, 2021, respectively. In Cohort A Parts 1 and 2, the efficacy and safety of combining margetuximab and retifanlimab (investigational anti-PD-1 monoclonal antibody licensed to Incyte by MacroGenics) is planned to be evaluated in approximately 100 patients whose tumors are HER2+ at the 3+ level by immunohistochemical (IHC) staining, PD-L1+ (combined positive score ≥1%) and non-microsatellite instability-high (non-MSI-H). A pre-specified interim analysis assessing efficacy and safety was conducted on the first 40 non-MSI-H patients enrolled in Part 1. These data support advancement to Part 2 with plans to enroll approximately 60 additional response-evaluable non-MSI-H patients.

A total of 43 HER2 3+ and PD-L1+ patients were enrolled in Cohort A Part 1 and received margetuximab 15 mg/kg plus retifanlimab 375 mg/kg administered intravenously every three weeks. Twenty-five patients (58%) had gastric cancer and 18 patients (42%) had gastroesophageal junction cancer; 36 patients (84%) had metastatic disease at study entry.

MAHOGANY Cohort A Interim Analysis

Anti-tumor activity was observed in patients treated with margetuximab plus retifanlimab in MAHOGANY Cohort A after the first scan. Tumor shrinkage was observed in 32 of 41 patients (78%) with at least one post-baseline target lesion measurement. Twenty-one of 40 response-evaluable patients achieved an objective response (53%, 95% confidence interval (CI): 36%-69%), including four confirmed complete responses and 17 confirmed partial responses. The number of confirmed responders by independent assessment exceeded the prespecified futility boundary for the trial, and enrollment is proceeding to Cohort A Part 2.

Disease control was achieved in 29 of 40 patients (73%, CI: 56%-85%) and the median duration of response was 10.3 months (range: 2.1 – 14.5 months, CI: 4.6 months – not evaluable (NE)). Median progression-free survival (PFS) was 6.4 months by independent assessment (CI: 6.0 months – NE); median overall survival (OS) was not yet reached. At both 12 and 18 months, OS was 85% (CI: 63%-95%).

Antitumor activity was comparable to historical data from the experimental arm of the Trastuzumab for Gastric Cancer (ToGA) study (trastuzumab + chemotherapy; n=294; objective response rate (ORR) of 47%; median duration of response (DOR) of 6.9 months)¹ and initial data from the control arm (placebo + trastuzumab + chemotherapy) of the KEYNOTE‐811 study (ORR of 52%; median DOR of 9.5 months).²

The safety analysis of all 43 patients treated with margetuximab plus retifanlimab suggests the combination was well tolerated in the study population. The most common TRAEs were fatigue (21% Grade 1-2, 0% Grade ≥3), infusion-related reaction (19% Grade 1-2, 0% Grade ≥3), rash (19% Grade 1-2, 0% Grade ≥3), diarrhea (16% Grade 1-2, 2% Grade 3), and pruritus (16% Grade 1-2, 0% Grade ≥3). A total of nine Grade 3 TRAEs were reported in eight patients (19%); no Grade 4 TRAEs were observed. Eight serious TRAEs were reported in seven patients. Infusion-related reactions considered as adverse events (AEs) of special interest occurred in six patients.

Treatment-emergent AEs of Grade 3 occurred in 18 of 43 patients (42%) of patients. Three of 43 patients (7%) discontinued therapy due to immune-related AEs: renal dysfunction (Grade 3), hepatitis (Grade 3), and diabetic ketoacidosis (Grade 1); no AEs led to death.

Safety data from MAHOGANY compare favorably to the experimental arm of ToGA in which overall Grade 3-4 AEs were 68% and the treatment-related mortality was 3%.¹ Initial results from KEYNOTE-811 data presented at the 2021 ASCO Annual Meeting indicated that AEs of Grade 3-5 occurred in 57.1% of patients in the experimental arm (pembrolizumab + trastuzumab + chemotherapy) and in 57.4% of patients in the control arm, AEs leading to death occurred in 3.2% vs 4.6%, and AEs leading to discontinuation of any study drug occurred in 24.4% vs 25.9% of patients, respectively. Despite limitations of cross-study comparisons, regimens containing chemotherapy may have clinically relevant safety differences compared to the chemotherapy-free regimen in MAHOGANY Cohort A.

“We are excited to share our results from the interim analysis of Part 1 of the MAHOGANY Cohort A study at ESMO,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “This study is designed to support potential registration of margetuximab in combination with other agents for patients with gastric or gastroesophageal junction cancer as part of our strategy to advance margetuximab in HER2+ cancer. The findings suggest the combination of margetuximab and retifanlimab may potentially provide a chemotherapy-free option as a first-line treatment for patients whose tumors are positive for both HER2 and PD-L1. We are pleased these data support the protocol’s prespecified advancement into Part 2 of MAHOGANY Cohort A. We plan to discuss these results and future development of the combination in an upcoming scheduled meeting with the FDA.”

ESMO Presentation

MacroGenics’ Cohort A Part 1 MAHOGANY Study poster presentation is available for on-demand viewing on the ESMO website and on the “Events & Presentations” page on MacroGenics’ website at http://ir.macrogenics.com/events.cfm.

The MAHOGANY Study Design

MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two cohorts designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2+ GEJ/GC.

Cohort A is designed as a single arm study to test margetuximab plus retifanlimab (previously known as MGA012 and INCMGA00012), an investigational anti-PD-1 monoclonal antibody, in patients with HER2+ and PD-L1+ tumors. The primary outcome measure for efficacy is ORR per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Cohort B is designed as a randomized trial to test margetuximab plus a checkpoint inhibitor in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2+ tumors irrespective of PD-L1 expression. Patients randomized to one of two experimental arms containing a checkpoint inhibitor will receive either retifanlimab or tebotelimab (previously known as MGD013), an investigational DART® molecule targeting PD-1 and LAG-3. The primary outcome measure for efficacy is OS.

The Phase 2/3 clinical trial is being conducted at clinical sites globally, in collaboration with Zai Lab, the company’s regional partner in Greater China. For additional information about the MAHOGANY study, please visit https://clinicaltrials.gov/ct2/show/NCT04082364.

About Gastric and Gastroesophageal Junction Cancer

Cancer of the stomach (gastric cancer, GC), or the gastroesophageal junction (GEJ) where the esophagus joins the stomach, is collectively known as gastroesophageal adenocarcinoma and is the fifth most common tumor type worldwide. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2+.

About Margetuximab

MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ GC or GEJ cancer in combination with a checkpoint inhibitor, with or without chemotherapy. Margetuximab is an Fc-engineered monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Through MacroGenics’ Fc Optimization technology, margetuximab has been engineered to enhance the engagement of the immune system.

Margetuximab is also being evaluated in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2+ tumors (NCT03219268). MacroGenics is partnered with Zai Lab for the development and commercialization of margetuximab in Greater China. For more information, please visit www.clinicaltrials.gov.

About Retifanlimab

Retifanlimab is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under an exclusive global collaboration and license agreement. MacroGenics retains the right to develop its pipeline molecules with retifanlimab. Incyte is pursuing development of retifanlimab monotherapy in four potentially registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma, anal cancer and non-small cell lung cancer. Incyte and MacroGenics are each conducting multiple studies of retifanlimab in combination with other agents.

About Tebotelimab

Tebotelimab is an investigational, first-in-class bispecific DART molecule designed to provide co-blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies.

About MacroGenics, Inc.

MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including enrollment in clinical trials, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential, ” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA’s market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

¹ Bang YJ, et al., Lancet. 2010; 376 (9742): 687-697.

² Janjigian YY, et al., J Clin Oncol. 2021; 39 (suppl 15): 4013.

CONTACTS:
Chris James, M.D., Vice President, Investor Relations & Corporate Communications
Jim Karrels, Senior Vice President, CFO
1-301-251-5172,  [email protected]

September 16, 2021 2:48 am

MacroGenics Announces Preliminary Clinical Results from Phase 1 Cohort Expansion of the Ongoing MGC018 Study Presented at ESMO 2021 Virtual Annual Congress

Metastatic castration-resistant prostate cancer (mCRPC): 21 of 39 patients (54%) achieved ≥ 50% prostate-specific antigen (PSA) reduction; 10 of 16 (63%) RECIST-evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved partial responses (two confirmed and two unconfirmed)
Non-small cell lung cancer (NSCLC): 13 of 16 (81%) evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved unconfirmed partial responses
Manageable safety profile overall, with low rate (7%) of discontinuation due to treatment-related adverse events (TRAEs)

ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from dose expansion cohorts of the Company’s ongoing Phase 1 clinical trial of MGC018. This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA-alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset is being presented in a poster titled “MGC018, an Anti-B7-H3 Antibody-Drug Conjugate (ADC), in Patients with Advanced Solid Tumors: Preliminary Results of Phase 1 Cohort Expansion” (Poster #620P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

Cohort Expansion Results Update

As of the August 16, 2021 data cut-off, a total of 86 patients with advanced solid tumors were enrolled in the cohort expansion of MGC018 at the recommended Phase 2 dose (RP2D) of 3.0 mg/kg, administered intravenously every three weeks. The enrollment includes 40 patients with mCRPC, 21 patients with NSCLC, 16 patients with triple negative breast cancer (TNBC) and nine patients with melanoma. In addition, enrollment of patients with squamous cell carcinoma of the head and neck (SCCHN) was recently initiated. The safety analysis both in the poster and below includes all enrolled patients, whereas the efficacy analysis was limited to mCRPC and NSCLC patients, as enrollment continues in the other tumor cohorts.

In the cohort expansion, tumor response by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was evaluated every nine weeks for all patients and PSA was assessed every three weeks in mCRPC.

Preliminary Anti-tumor Results for mCRPC Cohort Expansion

As of the August 16, 2021 data cut-off, all 40 patients in the mCRPC cohort expansion had been enrolled. Patients had previously received a median of three prior therapies for advanced disease, with all 40 patients having received both chemotherapy and next-generation hormonal therapy. The median B7-H3 H-score for all mCRPC patients was 223.

A total of 39 mCRPC patients were evaluable for PSA response. Reductions in PSA levels of ≥ 50% were observed in 21 of 39 patients (54%). Twenty-four of the 39 patients (62%) remained on treatment as of the data cut-off.

Of the 40 patients in the mCRPC cohort, 16 of the 23 patients with measurable disease were evaluable for tumor response by RECIST as of the data cut-off. Ten of these 16 patients (63%) had reductions in their target lesion sums from baseline. Four patients (25%) demonstrated a partial response (PR), consisting of two confirmed and two unconfirmed PRs. Treatment was ongoing in six of 16 patients with evaluable tumor response as of the data cut-off.

Preliminary Anti-tumor Results for NSCLC Cohort Expansion

As of the August 16, 2021 data cut-off, the NSCLC cohort expansion had been fully enrolled with 21 patients. Patients had previously received a median of two prior therapies for advanced disease, with 15 (71%) having previously received anti-PD-1/PD-L1 therapy. The median B7-H3 H-score for these patients was 139.

A total of 16 NSCLC patients were evaluable for tumor response by RECIST. Thirteen of 16 (81%) patients had reductions in their target lesion sums from baseline. Four of these 16 patients (25%) experienced unconfirmed partial responses. Another one of these 16 patients experienced a 30% reduction in target lesions; however, the patient’s non-target lesions were not evaluated due to an obstruction of the bronchus and overall response was not evaluable. Treatment was ongoing in seven of 16 patients as of the data cut-off.

Preliminary Safety Results

The safety analysis includes all 86 patients enrolled in the cohort expansion as of the August 16, 2021 data cut-off. The median number of doses received by mCRPC patients was 3.5 (range: 1-8); those with NSCLC received 3.0 (range: 1-7). Adverse events for the dose expansion cohorts of 3 mg/kg were generally consistent with those previously reported at ASCO 2021. TRAEs included hematologic and skin toxicities that have been clinically manageable to date. In the cohort expansion study overall, at least one TRAE of any grade was experienced by 78 of 86 patients (91%), with 43 of 86 patients (50%) experiencing a Grade ≥3 TRAE. There were two Grade 5 fatal events: one from an unknown cause and one due to SARS-CoV-2.

The most common TRAEs were fatigue (37% all grades; 1% Grade ≥3), neutropenia (34% all grades; 22% Grade ≥3), palmar plantar erythrodysesthesia syndrome (31% all grades; 4% Grade ≥3), pleural effusion (23% all grades; 1% Grade ≥3), nausea (22% all grades; 1% Grade ≥3), asthenia (20% all grades; 5% Grade ≥3) and thrombocytopenia (14% all grades; 7% Grade ≥3). The overall results have demonstrated a manageable safety profile with a low rate of treatment discontinuation due to TRAEs: only six of 86 (7%) patients had discontinued therapy in the cohort expansion as of the data cut-off date due to TRAEs.

“We are highly encouraged by the growing data from our ongoing Phase 1 study of MGC018,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Consistent with previously presented data, we observed PSA reductions of 50% or greater in 54% of patients with metastatic castration-resistant prostate cancer. And now, we are particularly pleased to see partial responses emerge – both confirmed and unconfirmed – in mCRPC and NSCLC patients, with encouraging anti-tumor activity observed in the majority of patients for both tumor types. Also, we are very pleased with the evolving safety profile of MGC018, which showed neutropenia as the only Grade 3 or higher TRAE that exceeded a rate of 10% in this trial. Finally, further optimization of patient management has resulted in a low rate of MGC018 discontinuation due to TRAEs as of the data cutoff. Enrollment is ongoing in the TNBC, SCCHN, and melanoma cohorts and we look forward to providing further updates on patients in these cohorts, as well as patients in the mCRPC and NSCLC cohorts, at subsequent scientific conferences.”

ESMO Presentation

MacroGenics’ MGC018 poster presentation is available for on-demand viewing on the ESMO website and on the “Events & Presentations” page on MacroGenics’ website at http://ir.macrogenics.com/events.cfm.

About MGC018

MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.

About MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of the Company’s therapeutic candidates, including enrollment in clinical trials, commercial prospects of or product revenues from MARGENZA®, milestone or opt-in payments from the Company’s collaborators, the Company’s anticipated milestones and other statements containing the words “subject to”, “believe”, “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA’s market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

CONTACTS:
Chris James, M.D., Vice President, Investor Relations & Corporate Communications
Jim Karrels, Senior Vice President, CFO
1-301-251-5172,  [email protected]

September 16, 2021 2:34 am

Leap Therapeutics Presents Updated Positive Data from the DisTinGuish Study of DKN-01 Plus Tislelizumab at the ESMO Congress

– DKN-01 plus tislelizumab and chemotherapy demonstrated compelling activity in first-line patients with gastric or gastroesophageal junction cancer

– Additional data presented today showed responses to treatment are independent of PD-L1 expression, with 79% ORR in patients with PD-L1 low (CPS < 5) tumors

– Company to host conference call on Friday, September 17, 2021 at 8:00 a.m. ET

PR Newswire

CAMBRIDGE, Mass., Sept. 16, 2021 /PRNewswire/ — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced the presentation of updated positive data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) Congress. The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

The Company announced positive initial data from the DisTinGuish study on Monday, September 13, 2021 based on 25 G/GEJ patients enrolled in the trial that showed DKN-01 in combination with tislelizumab and chemotherapy as first-line therapy was well tolerated with compelling activity. The results presented at the ESMO Congress today included additional patient data stratified by tumoral PD-L1 expression levels based on visually-estimated combined positive score (vCPS), showing that robust objective clinical responses can be achieved from this combination regimen independently of PD-L1 expression.

“Initial data from this trial have shown that patients with high levels of DKK1 expression, a group with a poor prognosis, had encouraging responses to treatment. The additional data presented today show evidence that not only is DKK1 a critical biomarker in predicting response to DKN-01 and tislelizumab therapy, but also that the combination can induce deep responses regardless of the patient’s PD-L1 status, including particularly poor prognosis patients with both low PD-L1 and high DKK1,” said Samuel Klempner, MD, Member of the Faculty at Massachusetts General Hospital Cancer Center and Harvard Medical School. “Taken together, these are promising results for the combination therapy of DKN-01 with tislelizumab and chemotherapy in first line patients with gastric or gastroesophageal junction cancers.”

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Key Findings

Among patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients and 56% in DKK1-low patients
Response was independent of PD-L1 expression, and particularly strong in the less favorable to checkpoint inhibitor therapy, PD-L1 low (vCPS < 5), population

Among those patients with PD-L1-low expression (vCPS < 5), the ORR was 79%, with 100% in DKK1-high patients and 57% in DKK1-low patients
Among those patients with PD-L1-high expression (vCPS ≥ 5), the ORR was 67%, with 75% ORR in DKK1-high patients and 50% in DKK1-low patients
DKK1 levels could not be determined in one patient who had PD-L1 expression data; however, the patient’s PD-L1 expression level was determined to be low (vCPS score 0) and the patient achieved a partial response

DKK1 expression and PD-L1 expression are not correlated
Median duration of response and progression-free survival data are not yet mature, and patient follow-up continues

Twenty-five first-line patients were enrolled, and as of the cut-off date of the presentation, 15 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), and three patients were unable to complete a full cycle of DKN-01 therapy (non-modified ITT (mITT)).

Among the 21 patients that had RNAscope® DKK1 expression available, 12 were DKK1-high [9 PR, 1 NE, 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD].

Among the 20 patients that had PD-L1 expression available, 14 were PD-L1 low vCPS < 5 [11 PR, 3 SD] and 6 were PD-L1 high vCPS > 5 [4 PR, 1 SD, 1 NE].

A copy of the poster presentation is available on the Company’s website at https://www.leaptx.com/our-pipeline.

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr. Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at https://investors.leaptx.com/, where a replay of the event will also be available for a limited time.

About Leap Therapeutics

Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a strategic partnership with BeiGene, Ltd. for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New Zealand. For more information about Leap Therapeutics, visit http://www.leaptx.com or view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.

RNAscope® is a registered trademark of Advanced Cell Diagnostics, Inc., Newark, CA, USA.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap’s expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestone, or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the SEC, including Leap’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed with the SEC on March 12, 2021 and as may be updated by Leap’s Quarterly Reports on Form 10-Q and the other reports Leap files from time to time with the SEC. Any forward-looking statement contained in this release speaks only as of its date. Leap undertakes no obligation to update any forward-looking statement contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT:

Douglas E. Onsi

President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
[email protected]

Heather Savelle

Investor Relations
Argot Partners
212-600-1902
[email protected]

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SOURCE Leap Therapeutics, Inc.

September 16, 2021 2:33 am

Oracle and Oxford Nanopore Team Up to Improve Healthcare and Speed Discovery of New Medical Breakthroughs

Technology leaders to jointly explore accessible, high-performance DNA/RNA sequencing solutions powered by Oracle Cloud Infrastructure (OCI) to improve patient care and outcomes

PR Newswire

AUSTIN, Texas, Sept. 16, 2021 /PRNewswire/ — Advances in DNA/RNA sequencing promise to revolutionize how medical communities identify, detect, and treat diseases and manage public health threats. To make this technology more accessible and increase its impact, Oracle has teamed up with Oxford Nanopore Technologies, the company behind a new generation of high-performance, rapid, scalable, and accessible sequencing technology.

Oracle and Oxford Nanopore have recently begun a collaboration to jointly explore several potential new solutions that would use genomic sequencing running on Oracle Cloud Infrastructure (OCI) to help speed medical breakthroughs and improve patient care.

Scientific researchers in more than 100 countries are already using nanopore sequencing to further their understanding of biology in a range of areas including human and cancer genetics as well as plant, animal, and environmental analyses. In addition, nanopore sequencing has been used for pathogen analysis, including the outbreak surveillance of tuberculosis, food-borne pathogens, Ebola, Zika, Lassa fever, dengue fever, influenza, and most recently COVID-19.

As part of the collaboration, Oxford Nanopore will be using OCI in applied and clinical markets. Leveraging the high performance, security, and extensive reach of Oracle Cloud, Oracle and Oxford Nanopore will have the ability to extend population-scale genetic sequencing across the globe.

The organizations will also take on several ambitious projects spanning epidemiology, whole-genome sequencing, and healthcare and drug discovery. This includes integrating Oxford Nanopore’s DNA/RNA sequencing capabilities and data into Oracle’s broad portfolio of healthcare and life sciences applications to strengthen the links between genomics, medical treatment, and drug development.

“Oxford Nanopore’s innovative sequencing technology is unparalleled in the market for its ability to generate rich, accurate genomic data at any scale, from handheld devices to ultra-high output installations,” said Mike Sicilia, executive vice president of Oracle Vertical Industries. “By integrating genomic data into our existing applications and cloud infrastructure solutions, we can get these powerful tools into the hands of more people to solve critical health issues faster and improve patient outcomes to usher in a new era of genomic breakthrough.”

In parallel, Oracle has committed to investing £150 million in Oxford Nanopore, subject to customary conditions.

About Oracle
Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at oracle.com.

Trademarks
Oracle, Java, and MySQL are registered trademarks of Oracle Corporation.

“Safe Harbor” Statement
This press release contains forward-looking statements including, among other things, statements relating to (1) a memorandum of understanding between Oracle and Oxford Nanopore Technologies, whereby the two companies will explore collaboratively a number of potential new solutions to address opportunities in applied and clinical markets and related go-to-market strategies, including Oxford Nanopore Technologies’ migration of its EPI2ME platform to the Oracle Cloud Infrastructure and (2) Oracle’s commitment to invest $150 million in Oxford Nanopore Technologies. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The degree to which the parties collaborate, the migration of the platform and the success of the foregoing, as well as the consummation of the investment, are subject to many factors that could cause actual results to differ materially. A detailed discussion of these factors and other risks that affect our business is contained in our SEC filings, including our most recent reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.” All information set forth in this press release is current as of September [13], 2021. Oracle undertakes no duty to update any statement in light of new information or future events.

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SOURCE Oracle

September 16, 2021 2:33 am

Athenex Presents Data from Oral Paclitaxel + Pembrolizumab Phase 1 Study at ESMO 2021

Safety Data Help Establish Part B Dose Expansion and Phase 2 Dose; Data showed encouraging anti-tumor activity (4 PR out of 8 evaluable patients) in NSCLC patients who failed prior PD1/PDL1 therapies

BUFFALO, N.Y., Sept. 16, 2021 (GLOBE NEWSWIRE) — Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced today the presentation of data from a Phase 1 study to assess the safety, tolerability, and activity of oral paclitaxel and encequidar (Oral Paclitaxel) in combination with pembrolizumab in patients with advanced solid malignancies. The data are being presented in a poster presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, being held from September 16^th to September 21^st.

“The encouraging interim Phase 1 data suggest promising anti-cancer activity and expected safety and tolerability observations for oral paclitaxel with pembrolizumab in lung cancer patients who had progressed on PD1/PDL1 therapies,” said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. “PD1/PDL1 therapies are important treatments for lung cancer but most patients eventually progress, and those patients represent an area of high unmet medical need. We are currently working to confirm these data in the dose expansion phase of this study.”

Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Oral Paclitaxel + Encequidar) in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

The primary objective for the dose escalation phase of the study was to determine the maximum tolerated dose (MTD) and identify the recommended Phase 2 dose (RP2D) of Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid tumors.

The dose escalation phase of the study enrolled 21 patients. Activity data were presented on 17 patients who were evaluable for a response, including eight NSCLC patients as well as patients with head and neck cancer, uveal melanoma, oesophageal cancer, colon cancer and bladder cancer. Four patients had partial response, 10 patients had stable disease, and three patients had progressive disease. The duration on treatment ranged from 9 to 676+ days.

There were a total of 10 NSCLC patients enrolled, of which eight were evaluable for response. Four patients achieved partial response and four patients achieved stable disease. All had discontinued previous checkpoint inhibitor therapy due to progressive disease.

MTD of the combination was not reached. The RP2D in combination with pembrolizumab was selected as Oral Paclitaxel 270 mg QD Days 1-3 for 2 weeks of a 3-week cycle. The study is proceeding to expansion cohorts and will enroll additional patients with NSCLC to further evaluate the safety and clinical activity of Oral Paclitaxel with pembrolizumab.

About the Phase 1 Study of Oral Paclitaxel and Encequidar in Combination with Pembrolizumab

The Phase 1 study is an open-label dose-escalation design study, to be followed by a 2-arm expansion cohort. The dose escalation utilized the “3+3” design and eligible patients had metastatic or unresectable solid tumors for which pembrolizumab is an FDA approved therapy. The Oral Paclitaxel dose range explored was 270-330mg administered for 2 days up to a maximum of 5 days per week x 2 weeks of a 3-week cycle. Pembrolizumab 200mg IV was administered every three weeks. The primary objective for Part A of the study was to determine the maximum tolerated dose (MTD) and identify the recommended Phase 2 dose of Oral Paclitaxel in combination with pembrolizumab in subjects with advanced solid tumors. Secondary objectives included safety and tolerability, the pharmacokinetics of paclitaxel, and preliminary anti-tumor activity. MTD and dose limiting toxicities were determined based on toxicities observed during the first 3-week cycle of treatment. Response was determined by CT scan evaluated by RECIST 1.1 every 9 weeks. The Part B dose expansion phase will enroll subjects with NSCLC to further evaluate the activity, safety and tolerability of the study treatment.

For further information about the study, visit ClinicalTrials.gov, identifier: NCT03588039.

About Athenex, Inc.

Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.

Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to agree with the FDA on a new clinical study for oral paclitaxel that is capital and time efficient; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to our ability to successfully integrate the business of Kuur into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its ongoing impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.

Athenex Contacts

Investors

Daniel Lang, MD
Athenex, Inc.
Email: [email protected]

Caileigh Dougherty
Athenex, Inc.
Email: [email protected]

September 16, 2021 2:33 am

Exelixis Announces CABOMETYX® in Combination with OPDIVO® Provides Efficacy Benefits Regardless of Prior Nephrectomy in Patients with Previously Untreated Advanced Renal Cell Carcinoma Based on CheckMate -9ER Analysis Presented at ESMO 2021

Exelixis Announces CABOMETYX® in Combination with OPDIVO® Provides Efficacy Benefits Regardless of Prior Nephrectomy in Patients with Previously Untreated Advanced Renal Cell Carcinoma Based on CheckMate -9ER Analysis Presented at ESMO 2021

– Progression-free survival and objective response rate benefits were observed with combination regimen versus sunitinib regardless of prior nephrectomy status –

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced results demonstrating efficacy benefits regardless of prior nephrectomy status with CABOMETYX^® (cabozantinib) in combination with Bristol Myers Squibb’s OPDIVO^® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). The data, from a post-hoc exploratory analysis of the phase 3 CheckMate -9ER pivotal trial, will be presented as an ePoster available on demand beginning at 8:30 a.m. CEST on Thursday, September 16 during the 2021 European Society of Medical Oncology (ESMO) Congress (abstract 663P).

“Patients with advanced kidney cancer who do not have a prior nephrectomy typically face an even worse prognosis than those who undergo the surgery,” said Camillo Porta, M.D., Full Professor of Medical Oncology at the A. Moro University of Bari, Italy, and presenting author. “It’s critical to gather more data such as this to help us better understand whether recent treatment advancements improve outcomes specifically for these patients. The consistent efficacy benefits demonstrated in the CheckMate -9ER trial regardless of prior nephrectomy status are reassuring as they continue to support the use of CABOMETYX in combination with OPDIVO for a broad range of patients with advanced kidney cancer.”

As previously announced, the phase 3 CheckMate -9ER pivotal trial showed that CABOMETYX in combination with OPDIVO improved overall survival (OS) and doubled median progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in patients with previously untreated advanced RCC. In this new exploratory analysis presented at ESMO 2021, at a median follow-up of 23.5 months, PFS and ORR benefits were observed regardless of prior nephrectomy status. The magnitudes of PFS and ORR benefits associated with CABOMETYX in combination with OPDIVO were greater in the subgroup of patients with prior nephrectomy versus those without prior nephrectomy. See table below for additional details.

“Building on prior subgroup analyses from CheckMate -9ER, we’re pleased to offer physicians these additional data that provide more insights into how the combination regimen may benefit specific subsets of patients with advanced kidney cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “Kidney cancer patients who do not have a prior nephrectomy are an especially difficult-to-treat subset of the patient community that is underserved and faces a particularly poor prognosis. We’re encouraged that these findings show that CABOMETYX in combination with OPDIVO is a valuable first-line treatment option that improves outcomes for these patients.”

Table

Outcome^*	Prior nephrectomy		No prior nephrectomy
Outcome^*	C+N n=222**	SUN* n=233**	C+N n=101	SUN n=95
Median PFS per BICR^a (95% CI^b), months	19.4 (15.6-22.9)	8.9 (7.0-10.4)	11.3 (8.8-16.0)	7.0 (5.5-9.4)
PFS HR^c (95% CI)	0.50 (0.39-0.64)		0.62 (0.43-0.89)
Median OS (95% CI), months	NR^d (NE^e)	NR (28.4-NE)	23.8 (21.4-NE)	29.5 (19.4-29.5)
OS HR (95% CI)	0.54 (0.37-0.78)		0.87 (0.57-1.35)
ORR per BICR (95% CI), %	60.8 (54.1-67.3)	30.5 (24.6-36.8)	41.6 (31.9-51.8)	23.2 (15.1-32.9)
Complete response per BICR, %	11.3	6.0	5.0	0.0
Duration of response per BICR (95% CI), months	22.0 (18.0-NE; n=135)	13.8 (8.7-NE; n=71)	17.2 (10.7-NE; n=42)	9.9 (4.9-NE; n=22)
* Data based on minimum follow-up of 16 months (median 23.5 months) for OS in ITT patients, acknowledging censoring at later timepoints. C+N: CABOMETYX in combination with OPDIVO * SUN: sunitinib ^a Blinded independent central review ^bConfidence interval ^c Hazard ratio ^d Not reached ^e Not estimable

In CheckMate -9ER, CABOMETYX in combination with OPDIVO was generally well tolerated and reflected the known safety profiles of the tyrosine kinase inhibitor and immunotherapy components in previously untreated advanced RCC. The most common adverse reactions reported in at least 20% of patients treated with CABOMETYX in combination with OPDIVO were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough and upper respiratory tract infection. A safety analysis with extended follow-up reported at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium identified no new safety signals; among patients treated with OPDIVO and CABOMETYX, 6.6% discontinued both agents due to treatment-related adverse events, 9.7% discontinued OPDIVO only and 7.2% discontinued CABOMETYX only.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic RCC with a clear cell component. A total of 651 patients (22% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1 ≥1%) were randomized to CABOMETYX at a dose of 40 mg once-daily and OPDIVO (n=323) versus sunitinib (n=328). The primary endpoint is PFS; secondary endpoints include OS and ORR. The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About RCC

The American Cancer Society’s 2021 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.¹ Clear cell RCC is the most common form of kidney cancer in adults.² If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%.¹ Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021.³

About 70% of RCC cases are known as “clear cell” carcinomas, based on histology.⁴ The majority of clear cell RCC tumors have below-normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.^5,6 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.^7,8,9,10 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.^6,7

About CABOMETYX® (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone.

Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade ≥2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade ≥2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade ≥2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation, and dysphonia.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

AboutExelixis

Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX^® (cabozantinib), COMETRIQ^® (cabozantinib), COTELLIC^® (cobimetinib) and MINNEBRO^® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune’s 100 Fastest-Growing Companies list for the first time, ranking 17^th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the presentation of data from the phase 3 CheckMate -9ER trial at ESMO 2021; the therapeutic potential of the combination of CABOMETYX and OPDIVO for a broad range of patients with advanced kidney cancer; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ and BMS’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating the combination of CABOMETYX and OPDIVO; Exelixis’ dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications and their adherence to their obligations under relevant collaboration agreements;Exelixis’ dependence on third-party vendors for the development, manufacture and supply of cabozantinib; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions, including as a result of the COVID-19 pandemic; and other factors affecting Exelixis and its development programs discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks of Exelixis. MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.

OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.

¹ American Cancer Society: Cancer Facts & Figures 2021. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf. Accessed September 2021.

²Jonasch, E., Gao, J., Rathmell, W., Renal cell carcinoma. BMJ. 2014; 349:g4797.

³ Decision Resources Report: Renal Cell Carcinoma. October 2014 (internal data on file).

⁴American Cancer Society: What is Kidney Cancer? Available at: https://www.cancer.org/cancer/kidney-cancer/about/what-is-kidney-cancer.html. Accessed September 2021.

⁵ Harshman, L., and Choueiri, T. Targeting the hepatocyte growth factor/c-Met signaling pathway in renal cell carcinoma. Cancer J. 2013; 19:316-323.

⁶Rankin, et al. Direct regulation of GAS6/AXL signaling by HIF promotes renal metastasis through SRC and MET. Proc Natl Acad Sci USA. 2014; 111:13373-13378.

⁷ Zhou, L., Liu, X-D., Sun, M., et al. Targeting MET and AXL overcomes resistance to sunitinib therapy in renal cell carcinoma. Oncogene. 2016; 35:2687-2697.

⁸ Koochekpour, et al. The von Hippel-Lindau tumor suppressor gene inhibits hepatocyte growth factor/scatter factor-induced invasion and branching morphogenesis in renal carcinoma cells. Mol Cell Biol. 1999; 19:5902–5912.

⁹ Takahashi, A., Sasaki, H., Kim, S., et al. Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis. Cancer Res. 1994; 54:4233-4237.

¹⁰ Nakagawa, M., Emoto, A., Hanada, T., Nasu, N., Nomura, Y. Tubulogenesis by microvascular endothelial cells is mediated by vascular endothelial growth factor (VEGF) in renal cell carcinoma. Br J Urol. 1997; 79:681-687.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210915006158/en/

Investors Contact:

Susan Hubbard

EVP, Public Affairs and

Investor Relations

Exelixis, Inc.

(650) 837-8194

[email protected]

Media Contact:

Lindsay Treadway

Executive Director, Public Affairs and Advocacy Relations

Exelixis, Inc.

(650) 837-7522

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Oncology Medical Supplies Health Other Health General Health Clinical Trials Pharmaceutical

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Posted on September 16, 2021 2:03 am
DZS and Freedom Fibre to Bring High-Performance Fiber Access to Over 130,000 New TalkTalk Subscribers in Northwest England

All-new, high-performance GPON/XGS-PON FTTx network for Tier 1 UK service provider TalkTalk leveraging integrated DZS OLT and ONT products

PLANO, Texas, Sept. 15, 2021 (GLOBE NEWSWIRE) — DZS (NASDAQ: DZSI), a global leader in broadband connectivity, mobile and optical transport, and software defined networking solutions, today announced collaboration with UK fiber network innovator Freedom Fibre to build an all-new, high-performance fiber network for nationwide telecom innovator TalkTalk, which serves over 4 million customers across the country. Already underway, the 18-month greenfield rollout will bring residential broadband services to over 130,000 subscribers in the northwest of England.

“Communities of all sizes the world over need exponentially greater bandwidth, and PON with its high performance and interoperability with existing services is the best solution for many new projects like the network that Freedom Fibre is building for TalkTalk,” said Charlie Vogt, President and CEO, DZS. “This combination of DZS technology and Freedom Fibre expertise is a win-win for TalkTalk and its residential subscribers, who will benefit from greatly improved connectivity and exceptional reliability. We applaud Freedom Fibre for its innovative, future-proof FTTx architecture that drives efficiency while enhancing quality, cost-effectiveness and value, whatever the bandwidth requirements.”

The DZS broadband access and edge access solutions form the backbone of Freedom Fibre’s large-scale GPON/XGS-PON deployment for TalkTalk:

DZS Velocity Broadband Access solutions, such as DZS Velocity V14 multi-terabit PON optical line terminals (OLTs), offer a highly scalable, high-performance aggregation platform for future-proof FTTx services. Ease of administration and support for an extended temperature range make DZS Velocity systems ideal for use in central or remote offices.

DZS Helix Edge Access solutions like the X-series 5302 provide full-featured yet affordable indoor XGS-PON single family unit (SFU) optical network terminals (ONTs) that delivers the full range of advanced IP voice, data and video services in a compact form factor, making it perfect for FTTH deployments demanding the utmost in reliable, high-speed data transport.

“Freedom Fibre is dedicated to driving change across the local area and beyond by working with service providers to optimize the UK’s fiber network,” said Darren Woods, CFO, Freedom Fibre. “We are proud that despite ongoing supply chain issues and other challenges that the pandemic has presented for businesses, we have, in collaboration with DZS, been able to seamlessly deliver a brand new network for TalkTalk that brings high-powered broadband access to thousands of homes. With its leading GPON and XGS-PON technology, DZS aligns perfectly with Freedom Fibre’s expertise and focus on rolling out high-performance FTTx networks with innovative architectures that deliver an optimal experience for the subscriber while saving time and costs for the operator.”

Uniquely positioned at the convergence of fixed and wireless networks with its 5G mobile edge transport, broadband connectivity and software-defined network solutions, DZS offers its customers and ecosystem partners complete and fully tested best-in-class solutions from one trusted source, along with the standards-based flexibility to avoid vendor lock-in and maximize the return on equipment investments while minimizing total cost of ownership (TCO) and initial capital expenses (CAPEX).

DZS is currently participating in the FTTH Virtual Conference (15-16 September 2021) and will have a stand at the Connected Britain conference at the Business Design Centre, London (21-22 September 2021).

For more information regarding DZS and its DZS Velocity fiber access solutions, visit https://dzsi.com/fttx/.

About DZS

DZS Inc. (NSDQ: DZSI) is a global leader in broadband connectivity, mobile and optical transport, and software defined networking solutions. With more than 20 million products in-service and customers and alliance partners spanning more than 100 countries, DZS is helping many of the world’s most advanced and innovative service providers and enterprises leverage to power of 5G, 10 gig fixed broadband, and software-defined networks to deliver cutting-edge services and lead in their markets.

DZS, the DZS logo, and all DZS product names are trademarks of DZS Inc. Other brand and product names are trademarks of their respective holders. Specifications, products, and/or product names are all subject to change.

This press release contains forward-looking statements regarding future events and our future results that are subject to the safe harbors created under the Private Securities Litigation Reform Act of 1995. These statements reflect the beliefs and assumptions of the Company’s management as of the date hereof. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” variations of such words, and similar expressions are intended to identify forward-looking statements. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. The Company’s actual results could differ materially and adversely from those expressed in or contemplated by the forward-looking statements. Factors that could cause actual results to differ include, but are not limited to, those risk factors contained in the Company’s SEC filings available at www.sec.gov, including without limitation, the Company’s annual report on Form 10-K, quarterly reports on Form 10-Q and subsequent filings. In addition, additional or unforeseen affects from the COVID-19 pandemic and the global economic climate may give rise to or amplify many of these risks. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. DZS undertakes no obligation to update or revise any forward-looking statements for any reason.

For further information see: www.DZSi.com.
DZS on Twitter: https://twitter.com/dzs_innovation
DZS on LinkedIn: https://www.linkedin.com/company/DZSi/

About Freedom Fibre

Freedom Fibre is based in the northwest of England and is dedicated to driving change across our local area and beyond. We partner with Internet Service Providers to optimise the UK’s fibre network and deliver the best possible subscriber experience while driving down costs and accelerating rollout speeds. With our knowledge and expertise, we innovate and challenge conventional thinking to deliver an inclusive, high-speed fibre infrastructure. Most of all, we enjoy what we do and are dedicated to making a difference.

Press Inquiries:

McKenzie Hurst, Thatcher+Co.
Mobile: +1 408.888.6787
Email: [email protected]

Posted on September 16, 2021 1:03 am
Vifor Pharma and Travere Therapeutics announce licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand

Vifor Pharma and Travere Therapeutics announce licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand

Sparsentan is a potential first-in-class treatment to address significant unmet medical need in rare kidney disorders focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)

Vifor Pharma obtains exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand

Travere receives a USD 55 million upfront payment and is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales

ST. GALLEN, Switzerland & SAN DIEGO, Calif.–(BUSINESS WIRE)–
Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210915005966/en/

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Pharma Group and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the companies have entered into a joint collaboration and licensing agreement for the commercialization of sparsentan in Europe, Australia and New Zealand. Sparsentan is a novel investigational product candidate currently being evaluated in pivotal phase-III clinical studies for the treatment of FSGS and IgAN, two rare progressive kidney disorders and leading causes of end-stage kidney disease. There are currently no approved medicines indicated for FSGS or IgAN. Sparsentan has been granted Orphan Drug Designation for the treatment of IgAN and FSGS in the U.S. and Europe.

Under the terms of the agreement, Vifor Pharma will receive exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand. Travere will receive an upfront payment of USD 55 million and be eligible for up to USD 135 million in payments tied to the achievement of certain regulatory and market access related milestones. Vifor Pharma will also make further payments in the form of sales milestones, and tiered double-digit royalties on net sales of sparsentan in Europe, Australia and New Zealand up to 40 percent at the high end of the royalty range.

“This agreement highlights that Vifor Pharma has become a company of choice for organizations committed to partnering innovative nephrology assets”, Abbas Hussain, CEO of Vifor Pharma Group commented. “With sparsentan, we will further expand our growing nephrology pipeline into FSGS and IgAN. There are currently no effective or approved therapies for these two rare kidney disorders, resulting in a significant unmet medical need among these patient populations. We look forward to working closely with Travere, who is responsible for the ongoing clinical development program of sparsentan, and to leveraging our commercial expertise to bring this highly promising, innovative treatment option to potentially more than 150,000 patients living with IgAN or FSGS in the licensed territories as soon as possible.”

“Our goal is for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; this collaboration marks an important step forward in this journey,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “Vifor Pharma is a global leader in nephrology with established commercialization expertise in Europe, Australia and New Zealand and this agreement aligns our two companies with the common goal of maximizing the number of people who can access sparsentan, if approved in these regions. In addition, this collaboration will further strengthen our financial foundation and allow our organization to focus on planned future launches of sparsentan in the U.S.”

Following the recently announced positive topline interim results from the ongoing pivotal phase-III PROTECT study of sparsentan in IgAN, Travere and Vifor Pharma will further evaluate the regulatory strategy for sparsentan in Europe, including the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022. Ultimately, the responsibility for and control over marketing authorizations in the licensed territories will be transitioned to Vifor Pharma. If sparsentan is approved, Vifor Pharma will be responsible for all commercialization activities in the licensed territories. Travere remains responsible for the clinical development of sparsentan and will retain all rights to sparsentan in the U.S. and rest of the world.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com.

About Travere Therapeutics

At Travere Therapeutics we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com.

About sparsentan

Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate. Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.

Sparsentan is currently being evaluated in the pivotal phase-III DUPLEX study for the treatment of FSGS and the pivotal phase-III PROTECT study for the treatment of IgAN. In February 2021, Travere announced that the ongoing DUPLEX study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, Travere announced that the ongoing PROTECT study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p<0.0001). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and performed consistent with the observed safety profile to date. In the phase-II DUET study of sparsentan in FSGS, the combined treatment group met its primary efficacy endpoint, demonstrating a greater than two-fold reduction in proteinuria compared to irbesartan, and was generally well tolerated after the eight-week, double-blind treatment period. Irbesartan is part of a class of drugs used to manage FSGS and IgAN in the absence of an approved pharmacologic treatment. If approved for both indications, sparsentan could potentially be the first medicine approved for both FSGS and IgAN.

Forward Looking Statements

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words “may”, “might”, “believes”, “thinks”, “anticipates”, “plans”, “expects”, “intends” or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: Travere’s goal for sparsentan to become the new global treatment standard for people living with FSGS and IgAN; the goal to maximize the number of people who can access sparsentan, if approved in the licensed regions; the ability of the collaboration to further strengthen Travere’s financial foundation; planned future launches of sparsentan in the U.S.; the potential to submit a joint marketing authorization application for both FSGS and IgAN in 2022; Vifor’s potential future achievement of regulatory, market-access and sales based milestones and Travere’s potential future receipt of payments therefrom; statements regarding the projected patient population in the licensed territory if sparsentan is approved; references to the efficacy, safety and tolerability profile of sparsentan based on the preliminary data from the DUPLEX and PROTECT Studies’ interim analyses; and the potential for sparsentan to become the first medicine approved for both FSGS and IgAN. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the regulatory review and approval process, including the conditional marketing authorization pathway in Europe, and the pricing and reimbursement landscape in the licensed territories, as well as ongoing clinical development risk. There is no guarantee that regulatory authorities in the licensed territories will accept a marketing authorization application for sparsentan or that sparsentan will receive conditional marketing authorization or be approved at all. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. Travere undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in Travere’s most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange Commission.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210915005966/en/

Media Relations

Nathalie Ponnier

Global Head Corporate Communications

+41 79 957 96 73

[email protected]

Investor Relations

Julien Vignot

Head of Investor Relations

+41 58 851 66 90

[email protected]

Travere Therapeutics:

Chris Cline, CFA

Senior Vice President, Investor Relations & Corporate Communications

+1 888-969-7879

[email protected]

KEYWORDS: California New Zealand Switzerland Australia North America Asia Pacific Europe United States Australia/Oceania

INDUSTRY KEYWORDS: Health Clinical Trials Research Pharmaceutical Science Biotechnology

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Posted on September 16, 2021 12:58 am
ForgeRock Announces Pricing of Initial Public Offering

ForgeRock Announces Pricing of Initial Public Offering

SAN FRANCISCO–(BUSINESS WIRE)–
ForgeRock, Inc. (ForgeRock), a global identity leader, today announced the pricing of its initial public offering of 11,000,000 shares of its Class A common stock at a price to the public of $25.00 per share. In addition, ForgeRock has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of Class A common stock at the initial public offering price, less underwriting discounts and commissions.

The shares are expected to begin trading on the New York Stock Exchange on September 16, 2021 under the ticker symbol “FORG”. The offering is expected to close on September 20, 2021, subject to customary closing conditions.

Morgan Stanley and J.P. Morgan are acting as lead book-running managers for the offering. Deutsche Bank Securities, Mizuho Securities, and HSBC are acting as joint book-running managers for the offering. BTIG, Cowen, Piper Sandler, Truist Securities, and William Blair are acting as co-managers for the offering.

The offering is being made only by means of a prospectus. When available, copies of the final prospectus may be obtained from: Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; and J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204, or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ForgeRock

ForgeRock^®, a global leader in digital identity, delivers modern identity and access management solutions for consumers, employees and things to simply and safely access the connected world. Using ForgeRock, more than 1,300 organizations around the world orchestrate, manage, and secure the complete lifecycle of identities from dynamic access controls, governance, APIs, and storing authoritative data – consumable in cloud or hybrid environments.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210915006215/en/

Media Contacts:

Kristen Batch, ForgeRock

[email protected]

Stacey Hurwitz, ForgeRock

[email protected]

Dillon Townsel, Edelman

[email protected]

Investor Relations Contacts:

Mark Kang, ForgeRock

Nicole Borsje, The Blueshirt Group

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Software Technology Data Management Security

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